Arnold & Porter Kaye Scholer LLP (LexBlog France)

Updated first-in-man guideline
On 20 July 2017, the EMA published the updated guideline on first-in-man (also known as phase I) clinical trials. First-in-man trials often carry the greatest risks, and have been the ones that generate the biggest headlines when they have gone wrong, for example the Phase I trial in France by Bial-Portela & CA SA in 2016....
First Advocate General Opinion on the Classification of Software Programs as Medical Devices
On 28 June, the Advocate General of the Court of Justice of the European Union gave his opinion on the SNITEM and Philips France case against France. In this case, the Conseil d’Etat in France asked whether a particular software program intended to be used by doctors to support prescribing decisions falls within the definition...

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